NCT01147146

Brief Summary

The effects of anesthetic method on cerebral oxygen saturation in geriatric patients undergoing transurethral surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

6 months

First QC Date

June 17, 2010

Last Update Submit

May 12, 2011

Conditions

Surgery

Keywords

transurethral surgery

Interventions

propofol, fentanyl, atracuriumDRUG

general anesthesia

Also known as: propofol 2mg/kg, fentanyl 50mg, atracurium 0.5mg/kg
bupivacaineDRUG

spinal anesthesia

Also known as: bupivacaine 8-10mg
bupivacaine, MidazolamDRUG

spinal anesthesia \& sedation

Also known as: Bupivacine 8-10mg, Midazolam 0.5mg/kg

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • male patients (ASA physical status I and II) aged over 65 yrs and scheduled elective transurethral surgery

You may not qualify if:

  • cardiovascular, renal, liver disease, or cerebrovascular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

PropofolFentanylAtracuriumBupivacaineMidazolam

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAnilidesAmidesAniline CompoundsAminesBenzodiazepinesBenzazepines

Study Officials

  • Jeong-Yeon Hong, MD

    Anesthesiology & Pain Medicine, Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

KR(1)